Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

Keynote-C93 : A Phase 3 Randomized, Open-label, Active-comparator Controlled Clinical Study of Pembrolizumab Versus Platinum Doublet Chemotherapy in Participants With Mismatch Repair Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma in the First-line Setting (KEYNOTE-C93/GOG-3064/ENGOT-en15)

Female<br/>OnlyGender Female
Only

RecruitingStatus Recruiting

Treatment<br/>TrialTypeTreatment
Trial

ThreePhase Three

18+Age Over 18

Female Reproductive<br/>System CancersCancer LocationFemale Reproductive
System Cancers

Treatment | Female reproductive organsEndometrium

Trial Overview Read MoreRead more

This phase III trial is evaluating how safe and effective immunotherapy (pembrolizumab) compared to chemotherapy (carboplatin and paclitaxel) is in people with mismatch repair deficient (dMMR) advanced or recurrent endometrial cancer who have not had prior systemic therapy.
 

This trial is treating patients with endometrial cancer.

This is a systemic therapy trial.

You may be able to join this trial if:

  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

A Phase 3 Randomized, Open-label, Active-comparator Controlled Clinical Study of Pembrolizumab Versus Platinum Doublet Chemotherapy in Participants With Mismatch Repair Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma in the First-line Setting (KEYNOTE-C93/GOG-3064/ENGOT-en15)

Cooperative Group

European Network of Gynaecological Oncological Trial Groups (ENGOT)

Commercial Sponsor

Merck

Summary

Eligible participants will be randomly allocated to either the Experimental Arm or Active Comparator Arm. In the Experimental Arm, participants will receive pembrolizumab (400mg) via intravenous infusion (IV) on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years). In the Active Comparator Arm, participants will receive a combination of paclitaxel (175mg/m^2) on Day 1 of each 3-week cycle and carboplatin (AUC 5 or 6) on Day 1 of each 3-week cycle for 6 cycles (up to approximately 4 months). Participants who experience a severe hypersensitivity reaction to paclitaxel or an adverse event (AE) requiring discontinuation of paclitaxel may receive docetaxel (75mg/m^2) in place of paclitaxel on Day 1 Q3W after Sponsor consultation. Participants who experience a severe hypersensitivity reaction to carboplatin or an AE requiring discontinuation of carboplatin may receive cisplatin (75mg/m^2) in place of carboplatin on Day 1 Q3W after Sponsor consultation.

Recruiting Hospitals Read MoreRead more

Monash Health, Medical Oncology
Clayton
Breast and Gynaecology Research Study Coordinator
breastgynae.oncresearch@monashhealth.org
0491299561

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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